Comparison of the Efficacy of Budesonide Nebulizer Suspension and Budesonide Inhalation Suspension in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease.

Background
Inhaled corticosteroids have been successfully used to improve lung function. Budesonide nebulizer suspension and Budesonide inhalation suspension are two inhaled corticosteroids used in treating chronic obstructive pulmonary disorder (COPD). We compared the efficacy of Budesonide nebulizer suspension and Budesonide inhalation suspension in the treatment of patients with acute exacerbations of COPD, to prioritize the two treatments.


Materials and Methods
In our study, 90 patients were recruited and divided randomly into two groups: Budesonide nebulizer suspension (Pulmicort Nebulizer) and Budesonide inhalation suspension (Pulmicort Turbuhaler) groups. Demographic characteristics, patient clinical information, and paraclinical data including arterial blood gases (ABG) and O2 Saturation were recorded both at the beginning of hospitalization and on the seventh day of treatment. The collected data were analyzed through independent sample t-test, paired sample t-test, chi-square test, and linear regression using SPSS version 20.


Results
Our findings revealed that there were no significant differences in O2SAT or ABG between the two groups at baseline or after seven days of treatment (P > 0.05). After seven days of treatment, mean O2SAT and arterial blood gases had increased significantly in each group (P < 0.001).


Conclusion
This study found no significant difference between the two groups with respect to the method of treatment. Therefore, Turbuhaler can be used at home by patients so, it leads to elimination of costs and hospital stays.

corticosteroids are the most effective anti-inflammatory medications used in the treatment of asthma (5). Such medications reduce the number of inflammatory cells and their activities in airways, and they are useful in treating asthma of any severity at any age (5-7). Many studies have shown that using inhaled corticosteroids in the treatment of patients who repeatedly experience acute exacerbations can decrease the severity of COPD by up to 25%. There is some evidence that inhaled steroids are effective in treating acute exacerbations of COPD and lead to increases in forced expiratory volume (FEV) (8)(9)(10)(11)(12).
Regular use of inhalant corticosteroids can be influential in improving lung function. Therefore, inhaled corticosteroids are usually used for treating hospitalized patients to decrease the length of stay in hospital, to decrease recurrence of exacerbations, or to accelerate recovery. Pulmicort Nebulizer and Pulmicort Turbuhaler are two inhaled corticosteroids that are used to treat COPD.
The aim of the present study was to identify and compare the effects of Pulmicort Nebulizer and Pulmicort Turbuhaler in the treatment of patients with exacerbations of COPD in order to identify a preferred treatment.

MATERIALS AND METHODS
The present study conducted among COPD patients According to GOLD guidelines defining acute exacerbations of COPD, the inclusion criteria were acute respiratory distress, increased duration and severity of coughs, increased amount and purulence of phlegm, or increased wheezing in the previous 24 hours. Those who had a history of asthma or respiratory distress before the age of 35, had no spirometric data, had taken steroids orally or through injection in the first month of disease appearance, had invasive mechanical ventilation through a tracheal tube, or had any other condition resulting in hospitalization were excluded from the study. Fisher's exact test or the chi-square test were used to compare qualitative variables, and the t-test was used to compare continuous variables between two groups. To compare O2SAT and ABG between the two groups, independent and paired t-tests were used separately and on the first and 7 th day after intervention. To identify factors affecting ABG variations in each group, regression analysis was used to adjust for confounders. In all analyses, we considered P < 0.05 to be significant.

RESULTS
The Pulmicort Turbuhaler group (n = 45) consisted of 34 males (75.6%) and 11 females (24.4%) with a mean age of 65.96 ± 10.39. The Pulmicort Nebulizer group (n = 45) consisted of 27 males (60.0%) and 18 females (40.0%) with a mean age of 69.96 ± 11.85. Statistically, both groups were the same in terms of age and gender (P > 0.05). There was no significant difference between the two groups in terms of COPD stage (P > 0.05).
Other clinical characteristics, including severity of dyspnea, amount of daily phlegm, number of COPD attacks, and laboratory results, are presented in Table 1.
The results showed that there was no significant difference in O2SAT or ABG between the two groups at the beginning of the study (P > 0.05). However, after 7 days of treatment, mean O2SAT increased significantly in both Pulmicort Turbuhaler (16.04) and Pulmicort Nebulizer groups (14.57), (P < 0.001). Results of ABG tests revealed that the pH level increased significantly after 7 days of treatment, while the partial pressure of carbon dioxide (pCO2) decreased significantly and bicarbonate (HCO3) increased significantly in both groups (P < 0.05). However, there was no significant difference between the two groups with respect to the method of treatment (Table 2).
In evaluating ABG factors, the results showed that the severity of dyspnea and the number of COPD attacks could have a significant effect on pH factors in the Pulmicort Turbuhaler group. The severity of dyspnea could also have a significant influence on both pCO2 and HCO3 factors; more acute dyspnea was associated with a smaller decrease in pCO2 and a smaller increase in HCO3 (P < 0.05). However, the severity of dyspnea had no significant effect on the levels of pCO2 or HCO3 in the Pulmicort Nebulizer group. The higher severity of dyspnea can be accompanied with decreased blood acidity (beta= -0.047, P =0.022). In some certain circumstances in which the patient condition can be intensively affected by those factors, it would be better but in common conditions and lack of cofounders it seems that turbuhaler is enough effective (Table 3).
Finally, three-month follow-up showed that there were 7 cases (15.6%) in the Pulmicort Turbuhaler group and 4 cases (8.9%) in the Pulmicort Nebulizer group who were hospitalized due to repeated exacerbations of COPD (Table   4).     (18). Although a previous study found Pulmicort to be the best choice for improving peak inspiratory flow rate (PIFR) and reduced exacerbations in vitro over dry powder inhaler (19), a combination of budesonide with other drugs-such as eformoterol-in a dry powder inhaler has been shown to be more beneficial in decreasing clinical symptoms and exacerbations in COPD patients (20). The nebulize Pulmicort with oral prednisolone could be an effective alternative (21).